Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429774
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-16
Brief Title:
Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain InjuryMetric-TBI
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury a Prospective Multicenter Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective multicenter observational cohort study is designed to compare the effectiveness of intervention in multi-grade hospitals for acute traumatic brain injury and to optimize clinical outcomes
Detailed Description:
Traumatic brain injury TBI is associated with significant morbidity mortality and disability profoundly impacting public health This study aims to establish a database for acute craniocerebral trauma within the Beijing-Tianjin-Hebei region and compiles indicators of hospital treatment capabilities and patient data including neuroimaging clinical progression and rehabilitation prognosesThe study is bifurcated into two segments the initial phase surveys the current status of acute treatment outcomes for TBI inpatients across hospitals in the Beijing-Tianjin-Hebei region and conducts a comparative effectiveness analysis to identify the clinical interventions to optimize Subsequent phases build on the former by applying optimized treatment strategies to improve efficacy and establish collaborative optimized treatment protocols
This is a prospective multicenter observational study designed to enroll 2000 patients under the age of 90 years with traumatic brain injury in the presence of clinical symptoms confirmed by computed tomography or magnetic resonance imagingThe primary outcome is the Extended Glasgow Outcome Score within 12 months Secondary outcomes include the Generalized Anxiety Disorder-7 GAD-7 Patient Health Questionnaire-9PHQ-9 Rivermead post-concussion symptoms questionnaireRPQ PTSD Checklist-5 VersionPCL-5Six-Item Screener SIS and 12-Item Short-Form Health Survey version 2SF-12v2
The objective of this study is anticipated to the Beijing-Tianjin-Hebei region a 20 percent increase in the number of cases treated by optimized clinical practice guidelines and a 10 percent decrement in mortality and disability rates among TBI patients in the region
This is a prospective multicenter observational study designed to enroll 2000 patients under the age of 90 years with traumatic brain injury in the presence of clinical symptoms confirmed by computed tomography or magnetic resonance imagingThe primary outcome is the Extended Glasgow Outcome Score within 12 months Secondary outcomes include the Generalized Anxiety Disorder-7 GAD-7 Patient Health Questionnaire-9PHQ-9 Rivermead post-concussion symptoms questionnaireRPQ PTSD Checklist-5 VersionPCL-5Six-Item Screener SIS and 12-Item Short-Form Health Survey version 2SF-12v2
The objective of this study is anticipated to the Beijing-Tianjin-Hebei region a 20 percent increase in the number of cases treated by optimized clinical practice guidelines and a 10 percent decrement in mortality and disability rates among TBI patients in the region
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None